Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-25 @ 11:03 PM
Study NCT ID:
NCT02853734
Status:
UNKNOWN
Last Update Posted:
2020-03-04
First Post:
2016-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammatory Status of Visceral Adipose Tissue in Obese Patients Related to Periodontitis Severity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004368', 'term': 'Dry Socket'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-03', 'studyFirstSubmitDate': '2016-07-26', 'studyFirstSubmitQcDate': '2016-07-29', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Collection of biological samples', 'timeFrame': 'Consecutively to samples collection (day before surgery, day of surgery)', 'description': 'Plasma, saliva and adipose tissue.'}], 'primaryOutcomes': [{'measure': 'Inflammatory status of visceral adipose tissue from obese patients depending on the presence and severity of periodontitis', 'timeFrame': 'Consecutively to visceral fat biopsy (day of surgery)', 'description': 'Measurements of major adipocytokines (Interleukine 6, Leptin, Adiponectin, Tumor Necrosis Factor-alpha, Monocyte Chemoattractant Protein-1, macrophage F4/80 receptor, CD11c, nuclear factor-kappa B, Toll Like Receptor 2/4 )'}], 'secondaryOutcomes': [{'measure': 'Detection of DNA for at least one type of periodontal pathogens in adipose tissue', 'timeFrame': 'Consecutively to visceral fat biopsy (day of surgery)', 'description': 'Aggregatibacter actinomycetemcomitans, Fusibacterium nucleatum, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola and Tannerella forsythia'}, {'measure': 'Description of the metabolic profile of patients relative to periodontitis severity', 'timeFrame': 'Consecutively to periodontal examination (day before surgery)', 'description': 'glycemia, insulinemia, glucose tolerance, plasma and HDL total cholesterol, triglycerides'}, {'measure': 'Link between adipose tissue inflammatory status, bacterial contamination and metabolic profile of patients', 'timeFrame': 'Consecutively to periodontal examination and fat biopsy (day before surgery, day of surgery)', 'description': 'adipose tissue inflammatory status, periodontal bacterial contamination,diabetic disorders, lipid metabolic profile of patients'}, {'measure': 'Link between the presence of periodontal pathogens in adipose tissue and their detection in saliva and plasma', 'timeFrame': 'Consecutively to periodontal examination and fat biopsy (day before surgery, day of surgery)', 'description': 'Detection of antibodies directed to periodontal bacteria in saliva and plasma'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parodontitis', 'Obesity', 'Metabolism Disorders']}, 'descriptionModule': {'briefSummary': 'The research aims to compare the inflammatory status of visceral adipose tissue from obese patients depending on the presence and severity of periodontitis, in order to establish a potential causal link between the severity of the bacterial contamination and insulin resistance.', 'detailedDescription': 'Recruitment of patients will be achieved in the department of digestive surgery. It will involve 122 patients with severe obesity undergoing bariatric surgery scheduled within the digestive surgery department. Patients recruited will be examined for evaluating the presence and severity of periodontitis, and separated into either group 1: for patients with moderate or severe periodontitis, and or group 2: for patients without or with mild periodontitis. The day before the surgery, blood sample will be collected for the analysis of circulating metabolic and inflammatory markers. Collection of stimulated saliva, periodontal sample and faeces samples (50 g) will also be carried out for bacteria determination. During the surgical procedure, a sample of visceral adipose tissue (50 g) will be collected and used for periodontal bacteria detection and inflammatory markers analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient eligible for bariatric surgery scheduled within the digestive surgery\n* Patient affiliated to Social Security system or equivalent\n\nExclusion Criteria:\n\n* Treatment with steroids or anti-inflammatory drugs in progress (or stopped for less than one month)\n* Patients who received antibiotics within 3 months prior to the bariatric surgery for whatever duration\n* Dental current (or older than 3 months)\n* Participation in another research protocol'}, 'identificationModule': {'nctId': 'NCT02853734', 'acronym': 'BACTERIOB', 'briefTitle': 'Inflammatory Status of Visceral Adipose Tissue in Obese Patients Related to Periodontitis Severity', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Comparative Evaluation of the Inflammatory Status of Visceral Adipose Tissue From Obese Patients According to the Presence and Severity of Periodontitis', 'orgStudyIdInfo': {'id': '2015/CHU/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SEVERE PERIODONTITIS', 'description': 'Periodontal examination Biological samples collection: periodontal, saliva, blood, fecal, visceral adipose tissue', 'interventionNames': ['Other: SEVERE PERIODONTITIS']}, {'type': 'OTHER', 'label': 'NO PERIODONTITIS', 'description': 'Periodontal examination Biological samples collection: periodontal, saliva, blood, fecal, visceral adipose tissue', 'interventionNames': ['Other: NO PERIODONTITIS']}], 'interventions': [{'name': 'SEVERE PERIODONTITIS', 'type': 'OTHER', 'description': 'Patients exhibiting moderate to severe periodontitis', 'armGroupLabels': ['SEVERE PERIODONTITIS']}, {'name': 'NO PERIODONTITIS', 'type': 'OTHER', 'description': 'Patients without existing periodontitis or exhibiting mild periodontitis', 'armGroupLabels': ['NO PERIODONTITIS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97448', 'city': 'Saint-Pierre', 'status': 'RECRUITING', 'country': 'Reunion', 'contacts': [{'name': 'Nathalie LE-MOULLEC, MD', 'role': 'CONTACT', 'email': 'nathalie.lemoullec@chu-reunion.fr', 'phone': '+262(0)262359164'}, {'name': 'Nathalie LE MOULLEC, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de La Réunion', 'geoPoint': {'lat': -21.3393, 'lon': 55.47811}}], 'centralContacts': [{'name': 'Emilie TECHER', 'role': 'CONTACT', 'email': 'emilie.techer@chu-reunion.fr', 'phone': '+262(0)262906289'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}